COMPASS Pathways and King's College London Announce Results From Psilocybin Study In Healthy Volunteers

London (ots/PRNewswire) - COMP360 (psilocybin) was well tolerated in healthy
volunteers and results support further investigation of simultaneous 1:1
therapeutic administration design

COMPASS Pathways, a mental health care company, has reported that its COMP360
(psilocybin) was well-tolerated when administered to healthy adult volunteers
with support from specially trained therapists in a randomised
placebo-controlled trial by King's College London. The results from the phase I
study, including data on safety and the feasibility of simultaneous 1:1
administration, were presented last night at the annual meeting of the American
College of Neuropsychopharmacology (ACNP). Psilocybin is an active ingredient in
so-called "magic mushrooms."

The study looked at the effects of 10mg and 25mg doses of COMP360, compared with
placebo, in 89 healthy volunteers. Doses were administered simultaneously to up
to six participants, who then received 1:1 psychological support from an
assisting therapist throughout the session, overseen by a lead therapist and
study psychiatrist.

Key results:

- There were no serious adverse events
- The majority of adverse events seen with the 10mg and 25mg doses
were of the expected psychedelic nature; the most frequent were
changes in sensory perception and positive mood alteration
- COMP360 had no negative effects on cognitive and emotional
functioning
- The study demonstrated the feasibility of administering COMP360 in
a controlled setting to healthy participants with 1:1 therapist
support, with up to six sessions running simultaneously

In 2018 COMPASS received FDA Breakthrough Therapy (https://www.prnewswire.com/ne
ws-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-p
silocybin-therapy-for-treatment-resistant-depression-834088100.html) designation
for its programme of psilocybin therapy in treatment-resistant depression.
COMPASS is currently running a phase IIb study across Europe and North America,
involving 216 patients who suffer with depression that hasn't responded to
established medications.

Dr Ekaterina Malievskaia, Chief Innovation Officer and Co-Founder, COMPASS
Pathways, said, "This study is part of our overall clinical development
programme in treatment-resistant depression; we wanted to look at the safety and
tolerability profile of our psilocybin, and to look at the feasibility of a
model where up to six 1:1 sessions are held at the same time. We are focused on
getting psilocybin therapy safely to as many patients who would benefit from it
as possible. We are grateful to the many pioneering research institutions whose
work over the years has helped to demonstrate the potential of psilocybin in
medicine."

Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in
Psychopharmacology at King's College London's Institute of Psychiatry,
Psychology & Neuroscience, and lead investigator of the study, said, "This is
the largest controlled study of psilocybin to date. The results of the study are
clinically reassuring and support further development of psilocybin as a
treatment for patients with mental health problems that haven't improved with
conventional therapy, such as treatment resistant depression."

About this phase I placebo-controlled trial of COMP360 in healthy volunteers

In this double-blind, placebo-controlled study, 89 healthy volunteers were
randomised in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30),
or placebo (n=29), with 1:1 support from a trained assisting therapist during a
session lasting about six hours. In total, 25 dosing sessions were completed,
with up to six participants per session. The study involved a 12 week follow-up
period.

About COMPASS Pathways

COMPASS Pathways is a mental health care company dedicated to accelerating
patient access to evidence-based innovation in mental health. We are developing
psilocybin therapy through a late-stage clinical trial in Europe and North
America for patients with treatment-resistant depression. COMP360 is an
investigational psilocybin formulation developed and produced by COMPASS
Pathways.

We think differently about mental health so you can too. www.compasspathways.com

About King's College London and the Institute of Psychiatry, Psychology &
Neuroscience

King's College London is one of the top 10 UK universities in the world (QS
World University Rankings, 2018/19) and among the oldest in England. King's has
more than 31,000 students (including more than 12,800 postgraduates) from some
150 countries worldwide, and some 8,500 staff.

The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College
London is the premier centre for mental health and related neurosciences
research in Europe. It produces more highly cited publications in psychiatry and
mental health than any other university in the world (Scopus, 2016), with 31 of
the most highly cited scientists in this field. World-leading research from the
IoPPN has made, and continues to make, an impact on how we understand, prevent
and treat mental illness and other conditions that affect the brain.

https://www.kcl.ac.uk/ioppn

@KingsIoPPN

Logo - https://mma.prnewswire.com/media/733890/COMPASS_Pathways_Logo.jpg

Enquiries:
Tracy Cheung, tracy@compasspathways.com (about:blank), +44 (0)796-630-9024
Amy Lawrence, amy@compasspathways.com (about:blank), +44 (0)781-377-7919

Additional content: https://www.presseportal.de/pm/131773/4465964
OTS: COMPASS Pathways

Original-Content von: COMPASS Pathways, übermittelt durch news aktuell